Antisoma's phase III trial of AS1413 completes patient enrolment

10-Sep-2010 - United Kingdom

Antisoma plc announces that the ACCEDE phase III trial of AS1413 (amonafide L-malate) in secondary acute myeloid leukaemia (secondary AML) is now fully enrolled. Data from the trial are expected in the first half of 2011, with filings for marketing authorisations to follow if these are positive.

ACCEDE is a single pivotal, randomised, controlled trial in which a regimen of AS1413 and cytarabine is compared with standard AML remission-induction therapy of daunorubicin and cytarabine ('7+3'). The primary endpoint of the study is the rate of complete remission with or without recovery of normal blood counts.

Over 420 patients from 22 countries have been included, making it the largest prospective trial ever conducted in patients with secondary AML.

Secondary AML is a significant subgroup of AML that develops from prior myelodysplastic syndrome (MDS) or follows treatment of another cancer with chemotherapy or radiotherapy. The disease is often multi-drug resistant and responds poorly to currently available therapies. A key feature of AS1413, and a potential advantage over many current AML treatments, is the drug's ability to evade multi-drug resistance mechanisms.

Glyn Edwards, CEO of Antisoma, said: "Completion of enrolment in the phase III trial is a critical milestone in the development of AS1413, and puts us on track to see the outcome in the near future. I would like to thank all the patients and physicians who have joined with us in seeking to improve the treatment of secondary AML."

AS1413 has orphan drug status in both the U.S. and the E.U. for the treatment of AML and recently received Fast Track status from the U.S. FDA for the treatment of secondary AML.

https://www.bionity.com/en/news/122681/antisoma-s-phase-iii-trial-of-as1413-completes-patient-enrolment.html